FDA 510(k)

RHEUMAGEN ASO T-CONTROL

K-Number: K904311 · 1991-01-25

Decision Date1991-01-25

Product CodeGTQ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

RHEUMAGEN ASO T-CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1991-01-25 under 510(k) number K904311. The device is classified under product code GTQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHEUMAGEN ASO T-CONTROL?

RHEUMAGEN ASO T-CONTROL is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Biokit USA, Inc.. The 510(k) number is K904311.

When did RHEUMAGEN ASO T-CONTROL receive FDA 510(k) clearance?

RHEUMAGEN ASO T-CONTROL received FDA 510(k) clearance on 1991-01-25, under 510(k) number K904311.

Who is the listed applicant for RHEUMAGEN ASO T-CONTROL?

The FDA 510(k) record lists Biokit USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RHEUMAGEN ASO T-CONTROL?

The FDA product code for RHEUMAGEN ASO T-CONTROL is GTQ.

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Other records listing Biokit USA, Inc. as applicant

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Related Devices (Code: GTQ)

K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;Ortho-Clinical Diagnostics K953437OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K915742TURBIQUANT ASLBehring Diagnostics, Inc.K926236BECKMAN ANTI-STREPTOLYSIN O KITBeckman Instruments, Inc.K924247ACCUTEX ASO LATEX TESTJ.S. Medical Assoc.K922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSimplicity Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.